FDA Devices recall · Reported March 11, 2015
Xoran MiniCAT X-ray imaging device
Out of tolerance kVp, Unexposed (black) frames, and Out of tolerance Dose.
Xoran Technologies, LLC recalled Xoran MiniCAT X-ray imaging device - a moderate-severity action.
Xoran MiniCAT X-ray imaging device was recalled by Xoran Technologies, LLC in March 11, 2015. Reason: Out of tolerance kVp, Unexposed (black) frames, and Out of tolerance Dose.. Check the official notice for the remedy. Verify recall #Z-1210-2015 with the FDA Devices before acting.
The recall
Xoran Technologies, LLC issued this moderate-severity FDA Devices recall-Out of tolerance kVp, Unexposed (black) frames, and Out of tolerance Dose..
- Moderate
- severity level
- 432 units
- affected scope
- Class II
- classification
- March 11, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1210-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1210-2015) was formally reported on March 11, 2015, with the manufacturer initiating the action on September 8, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Xoran Technologies, LLC is listed as the recalling firm, operating out of Ann Arbor, MI. Federal records list the affected scope as 432.
The documented reason for this recall is: Out of tolerance kVp, Unexposed (black) frames, and Out of tolerance Dose. Distribution data in the federal record shows the product reached: Nationwide Distribution. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Xoran MiniCAT X-ray imaging device
Reason for recall
Out of tolerance kVp, Unexposed (black) frames, and Out of tolerance Dose.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1210-2015 |
| Date reported | March 11, 2015 |
| Date initiated | September 8, 2014 |
| Recalling firm | Xoran Technologies, LLC |
| Firm location | Ann Arbor, MI |
| Affected scope | 432 |
| Distribution | Nationwide Distribution |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1210-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Methodology · Corrections · Archive as of August 2026